Label: MUCINEX COUGH CHEST CONGESTION- dextromethorphan hbr, guaifenesin capsule, liquid filled
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- NDC Code(s): 72854-137-16
- Packager: RB Health (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated September 19, 2022
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
■ helps loosen phlegm (mucus) and thin bronchial secretions
to rid the bronchial passageways of bothersome mucus
and make coughs more productive
■ temporarily relieves:
■ cough due to minor throat and bronchial irritation as
may occur with the common cold or inhaled irritants
■ the intensity of coughing
■ the impulse to cough to help you get to sleep -
Warnings
Do not use
■ if you are now taking a prescription monoamine oxidase
inhibitor (MAOI) (certain drugs for depression, psychiatric,
or emotional conditions, or Parkinson’s disease), or for
2 weeks after stopping the MAOI drug. If you do not know
if your prescription drug contains an MAOI, ask a doctor or
pharmacist before taking this product. - Directions
- Other Information
- Inactive Ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- KEEP OUT OF REACH OF CHILDREN
- Purpose
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
MUCINEX COUGH CHEST CONGESTION
dextromethorphan hbr, guaifenesin capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72854-137 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SORBITOL SOLUTION (UNII: 8KW3E207O2) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) GLYCERIN (UNII: PDC6A3C0OX) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) LIGHT MINERAL OIL (UNII: N6K5787QVP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) Product Characteristics Color green Score no score Shape OVAL Size 16mm Flavor Imprint Code AR08 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72854-137-16 2 in 1 CARTON 07/01/2022 1 8 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/01/2022 Labeler - RB Health (US) LLC (081049410)
